Update: Mutual Recognition Agreement between the U.S. and EU

As of July 11, 2019, the transitionary period is over, and enforcement of the Mutual Recognition Agreement (MRA) struck between the United States and the European Union is underway.

The US and EU

After years of examination, the US Food and Drug Administration (FDA) has verified that each of the EU’s 28 member states has the ability to produce human medicine in facilities operating in compliance with good manufacturing practice (GMP). Similarly, the European Commission (EC) confirmed that the FDA has adequate procedures in place to carry out GMP inspections at the same level as the EU.

What Does This Mean?

As a result, EU member states are no longer under obligation to batch-test human medicines covered under the MRA; the FDA can rely upon EU inspection results thereby eliminating redundant measures. The MRA affords both the FDA and EU the capacity to focus inspection efforts on medicines produced in facilities in other countries.

The new guideline primarily covers human drugs, biologics and veterinary drugs with a few exclusions. Veterinary products are not currently included but are likely to be considered by December 15, 2019. Current good manufacturing practices (CGMPs) of facilities manufacturing vaccines and plasma derived products are also not included but will be considered by July 15, 2022. The following products are not included and are not being considered:

  • Human blood
  • Human plasma
  • Human tissues and organs
  • Veterinary immunologicals

For a complete list of medicinal products covered under the MRA, click here.

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